KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis

September 20, 2011 updated by: University Hospital, Clermont-Ferrand

Acute Bronchiolitis in Infants: Analysis of a Biomarker of Epithelial Lung Injury - Clinical and Virological Correlation

Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity has consequences on immediate and later respiratory prognosis. Furthermore, this prognosis seems to be different according to the respiratory causative virus. The investigators propose to study, during an epidemic season, the correlation between KL-6 levels and clinical severity, and the type of viral infection.

Study Overview

Status

Unknown

Conditions

Detailed Description

Prospective, monocentric, case-control and transversal study Primary end-point: correlation between serum KL-6 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit Secondary end-points: respiratory virus detected by EIA and RT-PCR, phylogenetic study of rhinovirus, length of hospitalisation, immediate morbidity and mortality, risk of asthma at the age of three years old.

Study Type

Observational

Enrollment (Anticipated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

infants aged under 1 year

Description

Inclusion Criteria:

  • Cases: Inaugural acute bronchiolitis in infant aged under 1 year; bronchiolitis is defined by rhinorrhea and/or cough, dyspnea, associated with clinical or radiological distension, wheezing or crackling or brake expiratory.
  • Controls: Infant aged under 1 year with blood sample test performed for a non-infectious disease (preoperative assessment)

Exclusion Criteria:

  • Cases: bronchopulmonary dysplasia, prematurity, cystic fibrosis, immunodeficiency, primary ciliary dyskinesia, congenital cardiopathy, use of corticotherapy the week between inclusion
  • Controls: infectious documented disease, respiratory symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
KL-6 rate
Time Frame: At day 1
At day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: André LABBE, PU PH, CHU Estaing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

October 1, 2016

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (ESTIMATE)

September 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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